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Results For "United-States-Food-and-Drug-Administration"

395 News Found

Zydus receives final approval from the USFDA for Ivabradine Tablets
Drug Approval | December 06, 2023

Zydus receives final approval from the USFDA for Ivabradine Tablets

Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of USD 136.5 mn in the United States


Lupin launches Turqoz (Norgestrel and Ethinyl Estradiol) Tablets in US
Drug Approval | December 02, 2023

Lupin launches Turqoz (Norgestrel and Ethinyl Estradiol) Tablets in US

Norgestrel and Ethinyl Estradiol Tablets USP (RLD: Lo/Ovral-28) had estimated annual sales of US $33 million in the US


Lupin receives tentative approval from USFDA for Canagliflozin Tablets
Drug Approval | November 24, 2023

Lupin receives tentative approval from USFDA for Canagliflozin Tablets

Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor


Lupin receives approval from USFDA for Bromfenac Ophthalmic Solution
Drug Approval | November 24, 2023

Lupin receives approval from USFDA for Bromfenac Ophthalmic Solution

Bromfenac Ophthalmic Solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain


Lupin receives tentative approval from USFDA for Dapagliflozin Tablets
Drug Approval | November 22, 2023

Lupin receives tentative approval from USFDA for Dapagliflozin Tablets

Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US


Lupin receives approval from USFDA for Pitavastatin Tablets
Drug Approval | November 22, 2023

Lupin receives approval from USFDA for Pitavastatin Tablets

Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol


Lupin receives approval from US FDA for Ganirelix Acetate Injection
Drug Approval | November 20, 2023

Lupin receives approval from US FDA for Ganirelix Acetate Injection

The product will be manufactured at Lupin’s Nagpur facility in India


Dr. Reddy's rolls out drug-free non-invasive migraine management device ‘Nerivio’ in India
News | November 17, 2023

Dr. Reddy's rolls out drug-free non-invasive migraine management device ‘Nerivio’ in India

Nerivio is a prescription-based non-invasive device intended for acute and prophylactic (preventive) treatment of migrain


Lupin launches Rocuronium Bromide injection in US
Drug Approval | November 09, 2023

Lupin launches Rocuronium Bromide injection in US

Rocuronium Bromide Injection had estimated annual sales of USD 54 million in the US (IQVIA MAT August 2023).


Lupin receives USFDA tentative approval for Canagliflozin and Metformin Hydrochloride ER Tablets
Drug Approval | November 08, 2023

Lupin receives USFDA tentative approval for Canagliflozin and Metformin Hydrochloride ER Tablets

This product will be manufactured at Lupin’s Pithampur facility in India